Name: Predicase
Price: 199 USD

K-number	K213786
Device name	CiRX Single use electrosurgical pencil with non-coated and coated electrode
Applicant	Ningbo Shun YE Medical Company, Ltd.
Product code	GEI
Device class	Class II
Decision date	Jun 27, 2022
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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CiRX Single use electrosurgical pencil with non-coated and coated electrode

Everything you need for a 510(k) submission. Nothing you don't.